Four drug industry stakeholders say they support an FDA draft guidance proposing to reduce reliance on comparative efficacy studies when determining b...
FDA says it will start accepting applications on 2/1 for its new PreCheck Pilot program intended to boost domestic drug manufacturing capability.
FDA commissioner Marty Makary discusses upcoming actions to encourage more prescription-to-over-the-counter drug switches.
Cogent Biosciences says FDA has agreed to accept the companys planned NDA for cancer drug bezuclastinib under the agencys Real-Time Oncology Review pr...
FDA says its new ImportShield program improved processing speed and volume capacity while reducing staff hours in its first four months in operation.
Advanced Medical Technology Association urges FDA to narrow and clarify a draft guidance on quality management system information, warning that the cu...
Moderna and Merck report updated five-year follow-up data that show their personalized mRNA cancer vaccine candidate, intismeran autogene, significant...
FDA warns Temecula, CA-based Prodrome Sciences USA about violations in its conduct of a clinical trial without submitting an IND.
